Vessel Due F solution for i/v and i/m injection

Држава: Арменија

Језик: Енглески

Извор: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активни састојак:

sulodexide

Доступно од:

Alfasigma S.p.A.

АТЦ код:

B01AB11

INN (Међународно име):

sulodexide

Дозирање:

300LSU/ml

Фармацеутски облик:

solution for i/v and i/m injection

Јединице у пакету:

(10/2x5/) ampoules 2ml in blister

Тип рецептора:

Prescription

Статус ауторизације:

Registered

Датум одобрења:

2019-12-25

Карактеристике производа

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
VESSEL DUE F
®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Soft capsules:
Sulodexide 250 LSU
Ampoules:
Sulodexide 600 LSU
Excipients with known effects
Each soft capsule contains:
sodium ethyl para-hydroxybenzoate (E215): 0.26 mg per capsule
sodium propyl para-hydroxybenzoate: 0.13 mg per capsule
3.
PHARMACEUTICAL FORM
Soft capsules: brick-red, oval capsules containing a white to grey
suspension.
Solution for intravenous and intramuscular injection: clear not more
intensely coloured than
brownish-yellow sterile solution. pH: 5.5 – 7.5.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Chronic venous ulcers.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
VESSEL DUE F 250 ULS SOFT CAPSULES: 1 capsule twice a day away from
meals.
VESSEL DUE F 600 ULS/2ML SOLUTION FOR INJECTION: 1 ampoule a day for
intramuscular or
intravenous administration.
It is recommended to start the treatment with the ampoules and after
15-20 days continue
with the capsules for 30-40 days. The complete treatment course should
be repeated at
least 2 times a year.
The dosage may be changed in amount and frequency on the judgement of
the physician.
_Paediatric population _
The safety and effectiveness of sulodexide in children and adolescents
under 18 years of
age have not yet been established.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any one of the
excipients listed in section 6.1,
or to heparin or heparinoids.
Haemorrhagic diathesis and haemorrhagic diseases.
4.4
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
Tracebility
In order to improve the traceability of biological medicinal products,
the name and the
batch number of the administered product should be clearly recorded.
Due to the pharmaco-toxicological properties of sulodexide, the
product does not require
special precautions for use. However, during treatment with
anticoagulants, the
haemocoagulative parameters should be monitored periodically.
VESSEL DUE F soft capsules 250 LSU_ _contains s